Hologic NovaSure Advanced Instructions For Use And Controller Operator'S Manual Download Page 1 | Manualshive

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MAN-03523-001 Rev. 009

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Summary of Contents for NovaSure Advanced

Page 1: ......

Page 2: ...d the disposable device may contain a more recent revision of the NovaSure system instructions than the manual provided with the controller The NovaSure disposable device is not to be used with other...

Page 3: ...suctioning The disposable device is connected to the controller via a cord containing the RF cable suction tubing used for pressure monitoring during the cavity integrity assessment cycle and for suct...

Page 4: ...hyperplasia a patient with any anatomic condition e g history of previous classical cesarean section or transmural myomectomy or pathologic condition e g long term medical therapy that could lead to...

Page 5: ...the disposable device external to the patient to eliminate the risk of air or gas embolism The NovaSure RF controller CAVITY ASSESSMENT LED flashes red Model 08 09 RFCs or a purging device screen app...

Page 6: ...after inserting the disposable device and proceed directly from the seating procedure to the CIA Electrically conductive objects e g monitoring electrodes from other devices that are in direct contact...

Page 7: ...e g hormone D C or patient timing Patients randomized into the control arm received wire loop resection as an endometrial pretreatment Study endpoints The primary effectiveness measure was a validated...

Page 8: ...rameters between the treatment groups between the age groupings or among the nine investigational sites Table 2 Patient Accountability Number of Patients NovaSure Wire Loop Resection Plus Rollerball E...

Page 9: ...culty Performing Work Or Other Activities Due to Menses Pre operatively 66 3 65 5 Table 4 Effectiveness Quality of Life QOL NovaSure Wire Loop Resection Plus Rollerball 12 Months 9 9 8 6 24 Months 14...

Page 10: ...use only in women who do not desire to bear children because the likelihood of pregnancy is significantly decreased following the procedure Patients of childbearing capacity should be cautioned of pot...

Page 11: ...5 Press the toggle switch on the back panel of the controller into the on position 1 6 Connect the foot switch to the appropriate port on the front panel of the controller NOTE The first time the Mode...

Page 12: ...ay can be extended CONTRAINDICATION Do not treat a patient with a uterine cavity length that is less than 4 cm as cervical canal damage may occur NOTE Patients with a uterine cavity length greater tha...

Page 13: ...2 18 Unlock the disposable device by pressing the lock release button Close the disposable device by holding the front handle stationary and gently pulling the rear handle backwards until the closed...

Page 14: ...eeze the disposable device handles together while gently moving the disposable device 0 5 cm to and from the fundus and rotating the handle of the disposable device 45 counterclockwise from the vertic...

Page 15: ...m 2 34 Select the value indicated on the WIDTH dial into the NovaSure RF controller input screen by depressing the UP DOWN arrows 2 35 The system can be operated in either automatic mode or manual mod...

Page 16: ...ting 24 Replacement Instructions 24 Specifications 24 Cleaning and Sanitizing 28 Parts List 28 Warranty 28 Technical Support and Product Return Information 28 Symbol Definitions 29 MODEL 08 09 RF CONT...

Page 17: ...o be at the cervix and cannot be resolved by using the cervical collar use another tenaculum to grasp the cervix around the sheath Repeat the CIA by pressing the foot switch NOTE CO2 leakage may occur...

Page 18: ...modification of this equipment is allowed Periodic maintenance Recommended periodic maintenance includes RF power output testing and standard safety tests such as leakage current in accordance with UL...

Page 19: ...ated when the array is not fully deployed The ENABLE LED cannot be toggled on nor can power be delivered to the array when the ARRAY POSITION LED is illuminated VACUUM LED illuminates in two condition...

Page 20: ...e new device abort the procedure NOTE Removing the disposable device from the uterine cavity after completing a cavity integrity assessment will require an additional CIA test to be performed upon dis...

Page 21: ...2 leakage may occur at the external cervical os due to the presence of an over dilated cervix Visible bubbles or the hissing sound of escaping gas may accompany CO2 leakage under either of these condi...

Page 22: ...ng and standard safety tests such as leakage current in accordance with UL 60601 1 along with regular cleanings described in the Cleaning and Sanitizing section RF power output test The NovaSure RF co...

Page 23: ...r dilated cervix Visible bubbles or the hissing sound of escaping gas may accompany CO2 leakage under either of these conditions NOTE When following the troubleshooting steps on the Model 10 RFC press...

Page 24: ...t still displays proceed with the following 2 Attempt gentle reseating of the NovaSure disposable device A Partially retract the array into the sheath by releasing the disposable device handle lock re...

Page 25: ...ot appear Model 10 RFC Remove the NovaSure disposable device from the uterus after fully retracting the disposable device array into the sheath A Release the disposable device lock release button B Ho...

Page 26: ...ent into an outlet on a circuit different from that to which the other device s is are connected Contact Hologic Technical Support or the manufacturer of the other equipment for assistance 5 The contr...

Page 27: ...t s hand placed on her thigh should be avoided for example by insertion of dry gauze between skin surfaces WARNING With any electrosurgical device the potential for arcing exists and neuromuscular sti...

Page 28: ...lectromagnetic site survey should be considered If the measured field strength in the location in which the RF generator is used exceeds the applicable RF compliance level above the RF generator shoul...

Page 29: ...non Hologic Manufactured Equipment is warranted through its manufacturer and such manufacturer s warranties shall extend to Hologic s customers to the extent permitted by the manufacturer of such non...

Page 30: ...Follow instructions for use Fragile Fuse High pressure HP Humidity limitation non condensing Keep dry Manufacturer No oil Not made with natural rubber latex Protect from heat Radio frequency RF energ...

Page 31: ...MAN 03523 001 Rev 009...

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